Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin "EXPLORE-Xa"

Completed

Phase 2 Results

Summary of Purpose

Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 25 September 2017.

1 Oct 2008 26 Aug 2008 1 Aug 2009 1 Nov 2009 1 Jul 2017 20 Jul 2017
Start Date First Received 1st Completion Completion Verification Results

Trial Basics

Interventions

Conditions

Sponsors

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Contacts

  • 1st Contact: Virginia Frame, Ph.D. 610-989-4203 vframe@encorium.com 2nd Contact: Kevin Romanko, D.P.M. 650-246-7301 kromanko@portola.com

    vframe@encorium.com